OBJECTIVE： To evaluate the indicators of ADR reporting by medical institutions in China. METHODS： The indicators of ADR reporting by medical institutions in China were presented primarily by 8 pharmacy experts with focus group interview method. System assessment method was used for evidence-based analysis of primary ADR indicators. Delphi method was used to confirm the requirement， calculation formula， definition， evaluation meaning and reference value of ADR indicators. The reliability was assessed. RESULTS： Primary indicators included the rate of ADR reporting， the rate of qualified ADR， constituent ratio of severe and new ADR. A total of 30 literatures were included （15 documents of management standard， 15 literature research） in system evaluation， all of which indicated the necessity and requirement of ADR reporting. But the calculation formula， definition and evaluation meaning of ADR indicators were not mentioned. By investigation with Delphi method， the range of reference value was confirmed as follows that the rate of ADR reporting was≥0.01％； the rate of qualified ADR was≥90％； the constituent ratio of severe and new ADR was≥1％. The evaluation result was reliable. CONCLUSIONS： The indicators of ADR reporting and reference lower limit value can urge medical and health institutions to report ADR actively， improve the quality of ADR reporting and strengthen the attention of medical and health institutions to severe and new ADR.